Sepsis
Conditions
Keywords
Severe Sepsis
Brief summary
Adult Patients with Severe Sepsis
Detailed description
Compared with placebo, drotrecogin alfa (activated) reduces 28-day all-cause mortality in adult patients with severe sepsis at low risk of death (for example, with an Acute Physiology and Chronic Health Evaluation II (APACHE II) score \<25 or single organ dysfunction).
Interventions
Drotrecogin Alfa (activated)
DRUGPlacebo
0.9% sodium chloride
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients with recent onset of severe sepsis or presence of a suspected or proven infection, and at least one induced organ dysfunction.
Exclusion criteria
* Are indicated for the treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country. * Are contraindicated for treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country. * Platelet count less than 30,000/mm3.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy | 20 months |
Secondary
| Measure | Time frame |
|---|---|
| Safety | 20 months |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, Denmark, Egypt, Finland, France
Outcome results
None listed